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Folbee Plus

product on market Tablet or Pill Breckenridge Pharmaceutical Safety: 96/100
96/100

This product looks safe

  • Folic Acid: 5mg is 5.0× the Tolerable Upper Intake Level (1.0mg)
  • 78% of ingredients have research evidence
C Label Compliance Grade

What the Evidence Says

AI-generated · Qwen 3.6 · methodology

This formula contains a complex of B vitamins and folic acid, which are supported by strong evidence for maintaining neurological function and red blood cell production. These ingredients play critical roles in energy metabolism and cellular repair. The profile maintains a high safety score, though overall evidence coverage for this specific combination is limited.

AI-generated summary based on research evidence. Not medical advice.

Alerts

Safety Alerts

Folic Acid: 5mg is 5.0× the Tolerable Upper Intake Level (1.0mg)

Label

Product Label

Label for Folbee Plus
Open Full PDF View on NIH DSLD →
Details

Label Data

1 Tablet(s)
Serving Size
Vitamin
Product Type
78%
Evidence Coverage
Ingredients

Supplement Facts — Evidence Check

5 mg
Exceeds UL by 5.0× (UL: 1.0 mg) 226 studies (A:10, B:105)
416.7× RDA — above typical dose 139 studies (A:1, B:44)
1.5 mg
1.2× RDA — within safe limits 76 studies (A:0, B:33)
1.5 mg
1.2× RDA — within safe limits 13 studies (A:0, B:1)
50 mg
38.5× RDA — above typical dose (UL: 100 mg) 114 studies (A:3, B:35)
20 mg
1.4× RDA — within safe limits 196 studies (A:5, B:63)
Vitamin C
60 mg
2.0× RDA — within safe limits 2 studies — no high-quality reviews
300 mcg
10.0× RDA — above typical dose 27 studies (A:0, B:11)

Other Ingredients

Dicalcium Phosphate Microcrystalline Cellulose Croscarmellose Sodium Hypromellose Stearic Acid Titanium Dioxide Sodium Lauryl Sulfate Magnesium Silicate Triacetin Magnesium Stearate Mineral Oil
Claims

Label Claims — Verification

Unverified Nutrient
Unverified All Other
Unverified Structure/Function
Info

Product Information

Directions for Use

Dosage and administration: Usual adult dosage is one tablet daily, between meals, or as directed by a physician or health-care provider. For dialysis patients, Folbee Plus should be taken daily. On dialysis days, Folbee Plus Tablets should be taken after dialysis treatment.

Forbee Plus Tablets are labeled as a medical food intended for use under active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food.

Warnings & Precautions

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

To report a serious adverse event contact: 1-800-367-3395.

Do not use this product if the inner safety seal under the cap is torn, broken or missing.

This product is recommended for use under the supervision of a physician, or health-care provider.

Contraindications: Known hypersensitivity to any of the components in the products is a contraindication.

Warnings: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Do not exceed recommended dosage. Precautions: Folic acid when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in Folbee Plus Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing Folbee Plus Tablets.

Adverse reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine hcl. Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling or swelling of entire body has been associated with cyanocobalamin.

Drug interactions: Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparations containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

Patient information: Folbee Plus Tablets are for use only under the direction and supervision of a licensed physician or health-care provider.

Formulation Notes

Sugar and lactose free

Indications and usage: For the dietary management of individuals with distinct nutritional needs under a physician or health-care provider's supervision for end stage renal failure, dialysis, hyperhomocysteinemia or inadequate dietary vitamin intake.

Medical foods: Medical foods are intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of a normal diet alone. Although a medical-food product is intended for use under the active and ongoing medical supervision, FDA does not require a prescription.

Precautions: Folic acid when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in Folbee Plus Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing Folbee Plus Tablets.

Additional Information

All substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product.

Medical food

How supplied Folbee Plus Tablets are available as a yellow, film-coated, capsule-shaped tablet, debossed "B 082" in bottles or 90 tablets, 51991-082-90.

Store at 25(0)C (77(0)F); excursions permitted to 15(0)-30(0)C (59(0)-86(0)F). See USP controlled room temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Metadata

Product Details

UPC / SKU3 51991 08290 3
DSLD Entry Date2019-12-22
Product TypeVitamin
FormTablet or Pill
DSLD ID208639
Data Updated2026-04-11
Research

Research Evidence

363
Research Sources
57
Avg Quality
187
Meta Analysis
56
Systematic Review
54
Rct
29
Guideline
26
Clinical Trial
6
Cochrane Review
2
Regulatory Source
1
Other
1
Openfda Safety
A Homocysteine-lowering interventions for preventing cardiovascular events
Meta Analysis The Cochrane database of systematic reviews 2017 PubMed DOI
A Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes
Meta Analysis The Cochrane database of systematic reviews 2015 PubMed DOI
A Folate Intake and Risk of Pancreatic Cancer: A Systematic Review and Updated Meta-Analysis of Epidemiological Studies
Meta Analysis Digestive diseases and sciences 2021 PubMed DOI
A The Association Between the Risk of Hypertensive Disorders of Pregnancy and Folic Acid: A Systematic Review and Meta-Analysis
Meta Analysis Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques 2021 PubMed DOI
A A Comparative Study Evaluating the Effectiveness of Folate-Based B Vitamin Intervention on Cognitive Function of Older Adults under Mandatory Folic Acid Fortification Policy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Meta Analysis Nutrients 2024 PubMed DOI
A Associations between serum Homocysteine, vitamin B9, and vitamin B12 levels and the formation of intracranial Aneurysms: A systematic review and meta-analysis
Meta Analysis Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia 2025 PubMed DOI
A Intake of vitamin B6, folate, and vitamin B12 and risk of coronary heart disease: a systematic review and dose-response meta-analysis of prospective cohort studies
Meta Analysis Critical reviews in food science and nutrition 2019 PubMed DOI
A Beneficial effects of folic acid supplementation on lipid markers in adults: A GRADE-assessed systematic review and dose-response meta-analysis of data from 21,787 participants in 34 randomized controlled trials
Meta Analysis Critical reviews in food science and nutrition 2022 PubMed DOI
A Folic acid supplementation and blood pressure: a GRADE-assessed systematic review and dose-response meta-analysis of 41,633 participants
Meta Analysis Critical reviews in food science and nutrition 2023 PubMed DOI
A Digital tracking, provider decision support systems, and targeted client communication via mobile devices to improve primary health care
Meta Analysis The Cochrane database of systematic reviews 2025 PubMed DOI
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This product page is for informational purposes only and does not constitute medical advice. Always consult your healthcare provider before taking any supplement.